The FDA has made the approval packages for Boehringer Ingelheim’s Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved for the treatment of COPD by the FDA in May 2015. Spiriva Respimat tiotropium bromide SMI was approved for the treatment of COPD in September 2014 and for the treatment of asthma in September 2015.
The approval packages include .pdf copies of the approval letters for the products, labeling, and associated documents, including medical, pharmacology, chemistry, and risk assessment reviews.
View the FDA approval package for Stiolto Respimat.
View the FDA approval package for Spiriva Respimat.
